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ROCKVILLE, Md., April 29, 2020 (GLOBE NEWSWIRE) — Innovative Cellular Therapeutics (ICT), a clinical stage biotechnology company developing a comprehensive platform of chimeric antigen receptor (CAR) T cell therapies for solid and liquid tumors, today announced details of two abstracts on its novel CoupledCAR® solid tumor CAR-T technology for treating colorectal and thyroid cancers. The abstracts have been selected for oral presentation on May 15, 2020, at the 23^rd American Society of Gene & Cell Therapy (ASGCT) Annual Meeting, which will be conducted virtually.

“CoupledCAR® is ICT’s novel, in-house developed, proprietary CAR-T platform technology designed to overcome the challenges observed with conventional CAR-T therapies in treating solid tumors. CoupledCAR® significantly improves the expansion of CAR-T cells in vivo and enhances the CAR-T cells’ migration ability and resistance to immunosuppression in the tumor microenvironment. This allows the CoupledCAR® CAR-T cells to infiltrate tumor tissue sites and increase anti-tumor activities,” said Larry (Lei) Xiao, Ph.D., ICT’s Founder and Chief Executive Officer. “We are excited to share the strong human proof-of-concept efficacy results achieved with CoupledCAR® in China and have initiated pre-IND discussions with the FDA to advance our CoupledCAR® solid tumor CAR-T therapies into the clinic in the United States in the near future.”

ICT will present the two abstracts back-to-back in a virtual presentation on Friday, May 15, 2020, at 9:30 AM EDT, during the Clinical Trials Spotlight Symposium. The abstracts describe two heavily pre-treated patient cohorts with colorectal cancer and thyroid cancer, respectively, that achieved near Complete Remission (nCR) or Partial Remission (PR) after treatment with CoupledCAR®, and may be found here.

Novel CoupledCAR^® Technology for Treating Colorectal Cancer

Session Date/Time: Friday May 15, 2020 8:00 AM – 9:45 AM EDT
Session Title/Location: Clinical Trials Spotlight Symposium, Room 310
Presentation Time: 9:30 AM – 9:45 AM EDT
Presenter:  Larry (Lei) Xiao, PhD, Innovative Cellular Therapeutics 
Abstract Number: 1304

CoupledCAR^® Technology for Treating Thyroid Cancer

Session Date/Time: Friday May 15, 2020 8:00 AM – 9:45 AM EDT
Session Title/Location: Clinical Trials Spotlight Symposium, Room 310
Presentation Time: 9:30 AM – 9:45 AM EDT
Presenter: Larry (Lei) Xiao, PhD, Innovative Cellular Therapeutics
Abstract Number: 1303

About Innovative Cellular Therapeutics
Innovative Cellular Therapeutics (ICT) is a Rockville, Maryland-based clinical stage biotechnology company focused on the development of cellular immunotherapies for the treatment of solid and liquid tumors. ICT is in pre-Investigational New Drug (IND) discussions with the U.S. Food and Drug Administration (FDA) for its first solid tumor CAR-T programs, based on the Company’s proprietary CoupledCAR® solid tumor platform technology. ICT has already achieved promising responses with CoupledCAR® in thyroid, colon, and prostate cancer patients in human proof-of-concept trials through its Shanghai-based R&D platform. ICT is initiating its first U.S. clinical trial with its most advanced program, ICTCAR014, after having received FDA IND clearance in late 2019. ICTCAR014 is based on ICT’s proprietary ArmoredCAR® liquid tumor platform technology and is a next generation CD19-targeting CAR-T therapy that expresses a dominant negative PD-1 (dnPD-1) protein to block immunosuppression by cancer cells. ICTCAR014 is being developed for patients with relapsed or refractory non-Hodgkin lymphoma (NHL), including PD-L1 positive patients. For more information, please visit www.ictbio.com.  

Investor Relations Contacts:

Innovative Cellular Therapeutics
ir@ictbioinc.com

Irina Koffler
LifeSci Advisors
646-970-4681
ikoffler@lifesciadvisors.com

Media Relations Contact:

Kate L. Barrette
RooneyPartners LLC
212-223-0561
kbarrette@rooneyco.com

ROCKVILLE, Md., April 14, 2020 — Innovative Cellular Therapeutics (ICT), a clinical stage biotechnology company developing a comprehensive platform of chimeric antigen receptor (CAR) T cell therapies for solid and liquid tumors, today announced acceptance of its abstract titled Novel CoupledCAR® Technology for Treating Colorectal Cancer. The abstract will be presented orally at the 23^rd American Society of Gene & Cell Therapy (ASGCT) Annual Meeting, which will be conducted virtually, May 12-15, 2020.

“CoupledCAR® is ICT’s novel, in-house developed, proprietary CAR-T platform technology for the treatment of solid tumors. We have already achieved promising responses in several indications with CoupledCAR® in human proof-of-concept trials in China. We have also initiated pre-IND discussions with the FDA on taking several of our CoupledCAR® therapies into clinical trials in the United States,” said Larry (Lei) Xiao, Ph.D., ICT’s Founder and Chief Executive Officer. “We are excited for the opportunity to share our human data and strong efficacy results from our CoupledCAR® colorectal tumor program with the scientific community at ASGCT in May.”

The oral presentation of ICT’s abstract will be conducted virtually on Friday, May 15, 2020, at 9:30 AM EDT during the Clinical Trials Spotlight Symposium. Additional details are provided below.

Novel CoupledCAR^® Technology for Treating Colorectal Cancer

Session Date/Time: Friday May 15, 2020, 8:00 AM – 9:45 AM EDT
Session Title: Clinical Trials Spotlight Symposium
Presentation Time: 9:30 AM – 9:45 AM EDT

About Innovative Cellular Therapeutics

Innovative Cellular Therapeutics (ICT) is a Rockville, Maryland-based clinical stage biotechnology company focused on the development of cellular immunotherapies for the treatment of solid and liquid tumors. ICT is in pre-Investigational New Drug (IND) discussions with the U.S. Food and Drug Administration (FDA) for its first solid tumor CAR-T programs, based on the Company’s proprietary CoupledCAR® solid tumor platform technology. ICT has already achieved promising responses with CoupledCAR® in thyroid, colon, and prostate cancer patients in human proof-of-concept trials through its Shanghai-based R&D platform. ICT is initiating its first U.S. clinical trial with its most advanced program, ICTCAR014, after having received FDA IND clearance in late 2019. ICTCAR014 is based on ICT’s proprietary ArmoredCAR® liquid tumor platform technology and is a next generation CD19-targeting CAR-T therapy that expresses a dominant negative PD-1 (dnPD-1) protein to block immunosuppression by cancer cells. ICTCAR014 is being developed for patients with relapsed or refractory non-Hodgkin lymphoma (NHL), including PD-L1 positive patients. For more information, please visit www.ictbio.com. 

Investor Relations Contacts:

Innovative Cellular Therapeutics
ir@ictbioinc.com

Irina Koffler
LifeSci Advisors
646-970-4681
ikoffler@lifesciadvisors.com

Media Relations Contact:

Kate L. Barrette
RooneyPartners LLC
212-223-0561
kbarrette@rooneyco.com

ROCKVILLE, Md., March 10, 2020 (GLOBE NEWSWIRE) — Innovative Cellular Therapeutics (ICT), a clinical stage biotechnology company developing a comprehensive platform of chimeric antigen receptor (CAR) T cell therapies for solid and liquid tumors, announced today that it has been nominated as a finalist for “Emerging Life Sciences Company of the Year,” by Maryland Tech Council (MTC). The winner of the award will be revealed at MTC’s annual Industry Awards Celebration on May 13, 2020.

MTC is the largest technology trade group serving the advanced technology and biotechnology communities of Maryland. Its mission is to advocate for the interests of the technology community, further the role of technology in the Maryland economy, and nurture an environment where technology companies can collaborate, grow and succeed.

“We are honored to be nominated for the Emerging Life Sciences Company of the Year award by Maryland Tech Council,” said Larry (Lei) Xiao, Ph.D., ICT’s Founder and Chief Executive Officer. “After establishing our U.S. business in 2018, we moved our global headquarters to Rockville in early 2019 to further concentrate our focus on the U.S. market and to leverage the strong life sciences talent pool in Maryland as we expand our operations and hiring in the area.”

Dr. Xiao noted that ICT has already made significant progress since moving to Maryland, including hiring most of ICT’s senior executives and obtaining FDA IND clearance for the Company’s ArmoredCAR® ICTCAR014 CAR-T program, which is now moving into a U.S. Phase 1 clinical trial in relapsed or refractory NHL, including for PD-L1 positive patients. ICT has also initiated pre-IND discussions with the FDA for its first CoupledCAR^TM based solid tumor CAR-T programs.

“We appreciate the support and recognition from Maryland Tech Council and the local life sciences community during this exciting time for our company,” Dr. Xiao added.

About Innovative Cellular Therapeutics
Innovative Cellular Therapeutics (ICT) is a Rockville, Maryland based clinical stage biotechnology company focused on the development of cellular immunotherapies for the treatment of solid and liquid tumors. ICT is in pre-IND discussions with the U.S. Food and Drug Administration (FDA) for its first solid tumor CAR-T programs, based on the Company’s proprietary CoupledCAR^TM solid tumor platform technology. ICT has already achieved promising responses with CoupledCAR^TM in thyroid, colon, and prostate cancer patients in human proof-of-concept trials through its Shanghai based R&D platform. ICT is initiating its first U.S. clinical trial with its most advanced program, ICTCAR014, after having received U.S. FDA Investigational New Drug (IND) application clearance in late 2019. ICTCAR014 is based on ICT’s proprietary ArmoredCAR® liquid tumor platform technology and is a next generation CD19-targeting CAR-T therapy that expresses a dominant negative PD-1 (dnPD-1) protein to block immunosuppression by cancer cells. ICTCAR014 is being developed for patients with relapsed or refractory non-Hodgkin lymphoma (NHL), including PD-L1 positive patients. For more information, please visit www.ictbio.com.  

Investor Relations Contacts:

Innovative Cellular Therapeutics
ir@ictbioinc.com

Irina Koffler
LifeSci Advisors
646-970-4681
ikoffler@lifesciadvisors.com

Media Relations Contacts:

Kate L. Barrette
RooneyPartners LLC
212-223-0561
kbarrette@rooneyco.com

ROCKVILLE, Md., December 4, 2019 — Innovative Cellular Therapeutics (ICT), a biotechnology company developing a comprehensive platform of chimeric antigen receptor (CAR) T cell therapies for blood cancers and solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ICTCAR014, a next generation CD19-targeting CAR-T cell therapy that expresses a dominant negative PD-1 protein to block immunosuppression by cancer cells. ICT expects to initiate a U.S. clinical trial evaluating ICTCAR014 in patients with relapsed or refractory non-Hodgkin lymphoma (NHL), including patients whose tumors are PD-L1 positive, in the first part of 2020. Dr. David L. Porter of the Abramson Cancer Center of the University of Pennsylvania will be the Lead Principal Investigator for the clinical trial.

“The clearance of our first U.S. IND is a significant step as we expand our U.S. activities,” said Larry (Lei) Xiao, Ph.D., Chairman and Chief Executive Officer of ICT. “Building upon the encouraging data presented in November at the Society for Immunotherapy of Cancer (SITC), which showed objective response rate of over 92%, the ICTCAR014 program highlights our accelerated and de-risked approach for developing novel immunotherapies. Our development strategy translates rapid clinical proof-of-concept trials in China into U.S. and global development programs with the goal of regulatory approval through expedited review pathways. We look forward to advancing ICTCAR014 into our first U.S. clinical trial.”

About ICTCAR014

The U.S. Food and Drug Administration (FDA) has cleared ICT’s Investigational New Drug (IND) application for ICTCAR014, a next generation CD19-targeting CAR-T cell therapy that expresses a dominant negative PD-1 protein to block immunosuppression by cancer cells. ICT is moving ICTCAR014 into a U.S. clinical trial. ICTCAR014, referred to as an “armored” CAR-T cell therapy, has already demonstrated encouraging results in proof-of-concept human trials in China. As highlighted in ICT’s presentation at the November 2019 Society for the Immunotherapy of Cancer (SITC) meeting, ICTCAR014 demonstrated a 92.3% objective response rate (53.8% complete remission; 38.5% partial remission) in 13 initial patients with relapsed or refractory non-Hodgkin lymphoma. Significant tumor shrinkage and limited toxicity were observed.

About Innovative Cellular Therapeutics

Innovative Cellular Therapeutics (ICT) is a clinical stage biotechnology company focused on the development of cellular immunotherapies for the treatment of cancer. ICT has achieved promising preclinical and clinical results in late-stage leukemia and lymphoma with its next generation CAR-T constructs. ICT’s lead candidate in the U.S., ICTCAR014, is a next generation CD19-targeting CAR-T cell therapy that expresses a dominant negative PD-1 (dnPD-1) protein to block immunosuppression by cancer cells. ICTCAR014 is being developed for patients with relapsed or refractory non-Hodgkin lymphoma (NHL), including PD-L1 positive patients. ICT’s lead candidate in China, ICTCAR003, is a CD19-targeting CAR-T cell therapy for the treatment of B-cell acute lymphoblastic leukemia. The Company also has a broad pipeline of CAR-T candidates targeting solid tumors. For more information, please visit www.ictbio.com.

Investor Relations Contacts:

Bob Yedid
LifeSci Advisors
646-597-6989
Bob@lifesciadvisors.com

Media Relations Contacts:

Kate L. Barrette
RooneyPartners LLC
212-223-0561
kbarrette@rooneyco.com

ICT’s lead “armored” CAR-T program, ICTCAR014, demonstrated responses in two patients treated for refractory diffuse large B-cell lymphoma (DLBCL) in an investigator-sponsored clinical trial in China; safe and well-tolerated

Currently in preclinical development in the U.S. for the treatment of Non-Hodgkin Lymphoma

ROCKVILLE, Md., May 08, 2019 (GLOBE NEWSWIRE) — Innovative Cellular Therapeutics (ICT), a biotechnology company developing cellular immunotherapies for the treatment of cancer, announced the presentation of data from its ongoing investigator-sponsored clinical trial and preclinical studies of lead candidate ICTCAR014 in a poster presentation titled “Dominant negative PD1 Armored CART Cells Induce Remission in Refractory Diffuse Large B Cell Lymphoma (DLBCL) Patients” at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting held from April 28 – May 2, 2019 in Washington, D.C.

Additionally, Victor Lu, Ph.D., ICT’s Head of Regulatory Affairs, presented a talk titled “Manufacturing challenges during late phase development of gene therapy products – from a biotech company’s perspective” during a pre-Approval Commercialization Workshop at the meeting. The talk covered the challenges of manufacturing cell therapies for use in patients and methods to approach these challenges, including thorough product characterization, implementation of consistent manufacturing controls, and robust process validation and comparability studies.

“We are excited to announce the presentation of first-in-human clinical data from our lead therapeutic candidate, ICTCAR014, at ASGCT. Our investigator-sponsored clinical trial is a valuable source of human clinical proof-of-concept data for ICTCAR014, for which we intend to submit a U.S. IND for the treatment of Non-Hodgkin Lymphoma this year,” commented Lei Xiao, Ph.D., ICT’s Chief Executive Officer. “We are pursuing the opportunity to make a substantial difference for patients worldwide through our development of improved next-generation CAR-T therapies.”

ICT’s lead candidate, ICTCAR014, consists of anti-CD19 CAR-T cells with a dominant negative PD1 molecule. Preclinically, these “armored” CAR-T cells show enhanced capability of tumor killing after multiple-round tumor challenging and more “memory-like” phenotypes compared with conventional CAR-T cells. These results suggest dominant negative PD1 molecules may protect CAR-T cells from exhaustion in the tumor microenvironment and enhance anti-tumor efficacy by blocking the PD1-PDL1/2 interaction.

In an investigator-sponsored trial in China, two patients treated with ICTCAR014 for refractory diffuse large B-cell lymphoma (DLBCL) demonstrated significant tumor mass decrease as shown in PET/CT results and ongoing responses.

About Innovative Cellular Therapeutics

Innovative Cellular Therapeutics (ICT) is a biotechnology company focused on the development of cellular immunotherapies for the treatment of cancer. ICT is a clinical stage biotechnology company and has achieved promising preclinical and clinical results in late-stage leukemia and lymphoma with novel CAR-T constructs. ICT’s lead CAR-T candidate in the U.S., ICTCAR014, targets CD19 and PD1 for the treatment of Non-Hodgkin Lymphoma. ICT’s lead CAR-T candidate in China, ICTCAR003, targets CD19 for the treatment of B-cell acute lymphoblastic leukemia. The Company also has a broad pipeline of CAR-T candidates targeting other blood and liquid cancers and solid tumors. For more information, please visit www.ictbio.com.

ROCKVILLE, Md., March 19, 2019 (GLOBE NEWSWIRE) — Innovative Cellular Therapeutics (ICT), a biotechnology company developing cellular immunotherapies for the treatment of cancer, today announced it has successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA). At the meeting, the FDA provided feedback regarding ICT’s planned initiation of clinical trials under a U.S. IND for its lead CAR-T candidate, ICTCAR014, for the treatment of Non-Hodgkin Lymphoma (NHL).

“The positive feedback we received from the FDA during the pre-IND meeting was encouraging and aligns clearly with our plan to submit an IND for ICTCAR014 to the FDA in the second quarter of 2019,” said Lei Xiao, Ph.D., ICT’s Chief Executive Officer. “We appreciate the FDA’s support and guidance as we pursue our mission of bringing novel, targeted immunotherapies to the cancer patients that need them most.”

“The FDA was supportive of our detailed plan for U.S. clinical studies and provided helpful feedback on our proposed quality assurance and comparability experiments,” said Victor Lu, Senior Vice President and Head of Regulatory Affairs. “In following these recommendations, we are ensuring our compliance with the FDA’s established regulatory standards for gene modified cellular products. We have built a plan to address the FDA’s comments and are moving forward with the IND application process on our original timeline.”

To facilitate the clinical development of ICTCAR014 in the U.S., ICT recently established a new headquarters in Rockville, Maryland. It is also working with an American Contract Development and Manufacturing Organization to manufacture CAR-T cell product for clinical trials that will occur in different locations across the country. In anticipation of the phase 3 pivotal clinical trials and the BLA submission to the FDA, ICT is also laying the groundwork for commercial manufacturing capabilities of CAR-T technology in the U.S.

The Company’s lead program, ICTCAR014, is a novel “armored CAR” therapeutic candidate that targets CD19 and PD1. It is currently in preclinical development for the treatment of Non-Hodgkin Lymphoma in the U.S. Research has shown that the inhibition of PD1 may enhance CAR-T cell function.

About Innovative Cellular Therapeutics

Innovative Cellular Therapeutics (ICT) is a clinical stage biotechnology company focused on the development of cellular immunotherapies for the treatment of cancer. ICT has achieved promising preclinical and clinical results in late-stage leukemia and lymphoma with its next generation CAR-T constructs. ICT’s lead CAR-T candidate in the U.S., ICTCAR014, targets CD19 and PD-1 for the treatment of non-Hodgkin lymphoma. ICT’s lead CAR-T candidate in China, ICTCAR003, targets CD19 for the treatment of B-cell acute lymphoblastic leukemia. The Company also has a broad pipeline of CAR-T candidates targeting solid cancer tumors.

ROCKVILLE, Md., March 06, 2019 (GLOBE NEWSWIRE) — Innovative Cellular Therapeutics (ICT), a biotechnology company developing cellular immunotherapies for the treatment of cancer, today announced the opening of a U.S. office in Rockville, Maryland and the appointment of three new U.S.-based members of the executive team, a key corporate milestone for ICT. The new hires are Victor Lu, Ph.D., as Senior Vice President and Head of Regulatory Affairs; Brad Fackler as Senior Vice President, Operations and Business Development; and Timothy Mitchell as Vice President, Quality Assurance and Compliance.

“As we move toward our planned Phase I/II clinical trial initiation in lymphoma in 2019, we are excited to announce a significant U.S. presence out of our new offices in Maryland,” said Lei Xiao, Ph.D., Chief Executive Officer of ICT. “The hiring of team members to oversee our regulatory, clinical, and operational functions here in the United States represents an important milestone for our global company, and we are extremely well-positioned to carry out our clinical development plans.”

The Company’s lead program, ICTCAR014, is a novel “armored CAR” therapeutic candidate that targets CD19 and the PD1/PD-L1 pathway. It is currently in preclinical development for the treatment of Non-Hodgkin Lymphoma in the United States. Research has shown that the inhibition of PD1 may enhance CAR-T cell function.

More detailed biographies of the newly appointed team members are outlined below:

Victor Lu has over 18 years of experience in product development and regulatory affairs specific to cellular and gene therapies. Dr. Lu spent 10 of those years as a Reviewer with the FDA, where his main role was to review IND applications for cellular and gene therapy-based products and biologics license applications (BLAs), including for CAR-T Cells. Dr. Lu also has R&D experience from VIRxSYS Corporation, where he led the vector development effort for the first lentiviral vector-based gene therapy investigational product (VRX496) in human clinical trials. He holds a Ph.D. from the State University of New York at Buffalo in Molecular Virology and completed his postdoctoral training at the University of California San Francisco (UCSF).

Brad Fackler has over 35 years of experience in the pharmaceutical and biotech industries. Prior to joining ICT, he was the Senior Director of BioHealth and Life Sciences for Maryland’s Department of Commerce. Mr. Fackler has also held senior leadership positions with Novartis Pharmaceuticals, Sucampo Pharmaceuticals, and Cellona Therapeutics. He holds a B.A. in Biology from Otterbein University and an MBA from the Leonard Stern School of Business at New York University.

Timothy Mitchell has extensive experience in quality assurance within the human cell therapy, biologics, and pharmaceutical industries. His specific areas of focus include quality assurance and control, global compliance, validation, regulatory affairs, engineering, site management, and manufacturing operations. He was most recently the Head of Corporate Quality for Cell Therapy Technologies and Targeted Nuclear Oncology at Endocyte (a Novartis company). He has also held senior leadership positions with Celgene Corporation, Eli Lilly, and other companies. Mr. Mitchell holds a B.S. in both Genetic Biology and Biochemistry from Purdue University.

About Innovative Cellular Therapeutics

Innovative Cellular Therapeutics (ICT) is a clinical stage biotechnology company focused on the development of cellular immunotherapies for the treatment of cancer. ICT has achieved promising preclinical and clinical results in late-stage leukemia and lymphoma with its next generation CAR-T constructs. ICT’s lead CAR-T candidate in the U.S., ICTCAR014, targets CD19 and PD-1 for the treatment of non-Hodgkin lymphoma. ICT’s lead CAR-T candidate in China, ICTCAR003, targets CD19 for the treatment of B-cell acute lymphoblastic leukemia. The Company also has a broad pipeline of CAR-T candidates targeting solid cancer tumors.